Skip to content

Study for the efficacy and safety of oral arsenic realgar-Indigo naturalis formula combined with VRD regimen in the treatment of primary multiple myeloma

Study for the efficacy and safety of oral arsenic realgar-Indigo naturalis formula combined with VRD regimen in the treatment of primary multiple myeloma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023193
Enrollment
Unknown
Registered
2019-05-16
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma

Interventions

Experimental group:VRD protocol (Bortezomib, Lenadomide, Dexamethasone) + RIF
Control group:VRD protocol (Bortezomib, Lenadomide, Dexamethasone)

Sponsors

Huadong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. sign the informed consent; 2. patient with multiple myeloma, aged 18-80 years old, ECOG score 40%, no arrhythmia or heart rhythm instability, serum bilirubin < 2×normal limit, serum Alt < 4×normal limit, no chronic active hepatitis or cirrhosis of the liver, kidney function in CKD4 stage below, pregnancy test negative, for women with reproductive potential, consent of herself and family members.

Exclusion criteria

Exclusion criteria: 1) grade 4 hematological adverse reaction occurred during the treatment; 2) during the treatment, LV auxiliary device, intra-aortic balloon pump (IABP) or any type of detection means are used to detect end-stage heart failure, and coronary artery revascularization, electrophysiological device implantation, cardiac mechanical support implantation or other cardiac surgery are required due to the condition; 3) serious illness or with shorter life expectancy, make plan or difficult to explain the results of the study (cardiovascular disease (including New York heart association class for IV, congestive heart failure), respiratory, liver and nervous system, including treatment in stroke psychiatry or active malignancy (except the melanoma skin cancer is not out of scope or other major systemic disease; 4) any actual or expected other conditions (such as regional and social) that the researcher believes may limit the patient's participation during the study period; 5) specific regulations of any country that prevent patients from entering the study (e.g., restricted by judicial rulings or administrative orders); 6) during the study and follow-up, women of reproductive age were unwilling to take effective contraceptive measures or were unwilling or unable to receive pregnancy tests during the study; 7) disease developing during follow-up.

Design outcomes

Primary

MeasureTime frame
M protein;

Countries

China

Contacts

Public ContactChen Pingping

Huadong Hospital

focuslalala@163.com+86 13761612877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026